Stryker Sage PrimaFit Female Urine Management Systems recalled for undeclared latex adhesive
Sage Products is recalling approximately 174,960 Stryker Sage PrimaFit External Urine Management Systems in three lots because a small percentage may contain tape with undeclared natural rubber latex adhesive.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an allergen mislabeling case involving natural rubber latex, a common allergen. Although no illnesses have been reported, undeclared latex in skin-contact medical devices presents a direct risk to individuals with latex sensitivity, meeting the criteria for High (3) severity.
Plain-English summary
Sage Products Inc is recalling approximately 174,960 Stryker Sage PrimaFit External Urine Management Systems for the Female Anatomy. These devices are distributed in the United States and Canada, and the recall involves three specific lot codes: 93667, 93614, and 93613 (GTIN 00618029600417).
A small percentage of devices in the affected lots contain a tape with natural rubber latex adhesive that is not declared on the product label. This undeclared component may cause allergic reactions in individuals with latex sensitivity.
This is a Class II medical device recall issued by the FDA under recall number Z-0356-2024.
The recalled product
- Product
- stryker Sage PrimaFit External Urine Management System for the Female Anatomy
- Manufacturer
- Sage Products Inc
- Affected units
- 174,960
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- GTIN 00618029600417
- Lot Codes: 93667
- 93614
- 93613
Distribution
Distribution scope not specified by the agency.
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